Auditing Clinical Trials

Auditing Clinical Trials- 3 day seminar

Auditing is an essential part of clinical research quality management. Auditing requires a thorough comprehension of the application of GCP to apply as a standard to any observations identified. This class focuses on a systematic approach to auditing, using audit tools, applying standards to observations, and the corrective action plan recommendations. A repository of audit observations and recommendations are reviewed to enhance the learning experience and expand knowledge. Simulated case studies are used along with key line item data to develop the auditing skill set. This 3-day course is designed for new auditors or for experienced research professionals who want to add auditing to their skill set. The course is applicable to drug, biologic, and medical device studies.

Learning Objectives

• Describe the GCP audit process for Investigators and Sponsors/CRO.
• Discuss the application of applying GCP standards to observations.
• Implement the MRM Auditing techniques and tools to applying standards to observations.
• Identify the different pathways to recommendations for observation resolution based on type of findings.

Daily Agenda / Course Topics

DAY 1

• Overview of Investigation Product Development, FDA and ICH GCP obligations.
• The Types of Clinical Research Audits
• The Auditing System and the Audit Plan

DAY 2

• Auditing Tools and Techniques
• Identifying and Writing Audit Observations
• Classifying Audit Observations
• Observations and Recommendation and/or CAPA Plans
• Audit Drills to Develop Skills

DAY 3

• Hands On-Application of Auditing via Case Study Scenarios
• Includes selecting observation standards and recommendations

Who Should Take This Course

This 3-day course is designed for new auditors or for experienced research professionals who want to add auditing to their skill set. The course is applicable to drug, biologic, and medical device studies.

This course is designed for individuals with a minimum of 6 months clinical research experience. CRAs that do not have formal training, but are interested in learning skills that will enhance their monitoring activities and those who are transitioning into a CRA position will benefit from this course.

Dates / Times / Accommodations

Contact Hours

Florida State provider #50-11408, provider approved by the California board of registered nursing, provider #CEP 13617 for 16.5 contact hours. credits can be applied to ACRP certification.

Cancellations and Substitutions

Cancellations by registrants must be provided in writing prior to the start date of the seminar, such registrants shall receive a credit voucher toward a future MRM seminar. Companies may substitute someone registered with another participant at any time. MRM reserves the right to cancel a seminar due to poor enrollment or acts of nature and shall not be responsible for any airfare, hotel, or other costs. MRM shall offer a credit voucher to a future seminar or a complete refund for MRM Seminar cancellations. Seminar topics and speakers may be subject to change without any prior notice.